Yet Another Obesity Agent Fails to Impress FDA Panelists – Will a Suboptimal Risk-to-Benefit Ratio Seal the Fate of Arena’s Lorqess?

Based on our Pharmacor advisory service entitled Obesity, Decision Resources is offering an exclusive analyst call entitled Yet Another Obesity Agent Fails to Impress FDA Panelists – Will a Suboptimal Risk-to-Benefit Ratio Seal the Fate of Arena’s Lorqess? Because this presentation will feature major updates, it is ONLY available to purchasers of this Pharmacor advisory service.

Please contact us to learn how you can purchase this Pharmacor advisory service and attend the analyst call.

Arena’s Lorqess was the second obesity agent in recent months to receive a negative recommendation from an FDA advisory panel. Like Vivus’s Qnexa, which the FDA advisory committee recently voted against approving, there were safety issues surrounding Lorqess that concerned the committee. The main issues were the incidence of breast cancer in rodent studies and lingering concerns about cardiac valvulopathy due to Lorqess’s similarity to Wyeth’s Redux, an agent which is one half of the ill-fated fen-phen combination.

Although there were questions regarding its safety, the main issue that concerned panelists was Lorqess’s weak efficacy data—many panelists do not believe that the risk/benefit ratio warrants the use of this agent. As a result, the panel voted 9-5 vote against approval of Lorqess.

One day prior to the Lorqess’s negative recommendation, the FDA panel met to decide the fate of Abbott’s Meridia, which had already been withdrawn in Europe earlier this year following release of data from the SCOUT clinical trial. The panel remained divided as to whether Meridia should remain on the market. As a result, the future of the obesity drug market—which has been plagued by safety issues and a dearth of efficacious agents—remains uncertain at this time.

This 15-minute analyst call, presented by Analyst Kate Sullivan, will answer the following questions:

• What impact will the FDA advisory committee’s decision have on Lorqess’s future and on the obesity market forecast as a whole?
• How will this event affect the prospects for Orexigen’s Contrave, the third of the late-stage obesity therapies that will face FDA scrutiny in December?
• How is the FDA likely to react to the advisory panel’s split vote on Meridia?
• What is the outcome of Decision Resources' new market forecast following our analysis of the regulatory prospects for all three emerging obesity therapies?

Ms. Sullivan will conduct a live Q & A session after the presentation.

Registration

Yet Another Obesity Agent Fails to Impress FDA Panelists – Will a Suboptimal Risk-to-Benefit Ratio Seal the Fate of Arena’s Lorqess?

September 28, 2010 at 10 a.m. U.S. Eastern Time, 4 p.m. Central European Time (Paris).

To learn how you can purchase this Pharmacor advisory service and attend the analyst call, please contact us using the information below.

Contact Us

In North America — Keith Rourke at 781-993-2656 or krourke@dresources.com

In Europe — Kaj van Langendonck at +32-2-357-06-14 or kvanlangendonck@decisionresources.be

In Japan — Makiko Yoshimoto at +81-3-5401-2615 or makiko@dresources.jp

Terms of Use | Privacy Policy | Contact Us | Careers

Decision Resources • 8 New England Executive Park • Burlington, MA 01803

Register to receive our latest offers. You are receiving this email because you have previously requested information from Decision Resources.

© 2010 Decision Resources, Inc. All rights reserved.